AccessGUDID - DEVICE: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

GUDID

Device Identifier (DI) Information

Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - AORTIC
Version or Model: 2700TFX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2700TFX29MM
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103177213
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):
Over the Counter (OTC):
Kit:
Combination Product:
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60242	Aortic open-surgery heart valve bioprosthesis	A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DYE	replacement Heart-valve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P860057	001
P860057	004
P860057	019
P860057	022
P860057	023
P860057	030
P860057	036
P860057	039
P860057	045
P860057	051
P860057	053
P860057	062
P860057	100
P860057	104

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: MOUNTING DIAMETER (ANNULUS), 29 MILLIMETER

Device Record Status

Public Device Record Key: 0529ecac-76bd-405a-ae42-5dffb13a94d7
Public Version Date: May 22, 2025
Public Version Number: 5
DI Record Publish Date: August 30, 2014